Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/00131—Accessories for endoscopes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
  • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00477—Coupling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
  • A61B2034/2046—Tracking techniques
  • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
  • A61B2034/2046—Tracking techniques
  • A61B2034/2065—Tracking using image or pattern recognition
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0097—Catheters; Hollow probes characterised by the hub

Definitions

• This disclosure relates to medical instruments and more particularly to shape optical fiber registration tools and methods for use. Description of the Related Art
• Optical shape sensing uses a multi-core optical fiber to reconstruct shape along the length of a device.
• this reconstructed shape is then overlaid with either a pre-operative image (using e.g., computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy) or intraoperative image (such as, e.g., ultrasound or fluoroscopy).
• CT computed tomography
• MRI magnetic resonance imaging
• fluoroscopy intraoperative image
• intraoperative image such as, e.g., ultrasound or fluoroscopy
• an optical shape sensing hub includes a longitudinal body forming a cavity configured to receive two or more optical shape sensing (OSS) enabled instruments.
• OSS optical shape sensing
• One or more mechanical features are disposed within the cavity or on the longitudinal body to maintain the two or more OSS enabled instruments in a fixed geometrical configuration relative to one another such that distally to the longitudinal body the two or more OSS enabled instruments have shape sensed reconstruction data registered therebetween.
• a shape sensing system includes a hub comprising a longitudinal body forming a cavity configured to receive two or more optical shape sensing (OSS) enabled instruments, the hub including one or more mechanical features disposed within the cavity or on the longitudinal body to maintain the two or more OSS enabled instruments in a fixed geometrical
• a shape sensing module is configured to receive, interpret and register optical signals from optical fibers of the two or more OSS enabled instruments to determine shapes of the two or more OSS enabled instruments.
• a method for registering two or more an optical shape sensing (OSS) enabled instruments includes providing an optical shape sensing hub comprising a longitudinal body forming a cavity configured to receive two or more optical shape sensing (OSS) enabled instruments, and one or more mechanical features disposed within the cavity or on the longitudinal body to maintain the two or more OSS enabled instruments in a fixed geometrical configuration relative to one another such that distally to the longitudinal body the two or more OSS enabled instruments have shape sensed reconstruction data registered therebetween; generating a hub template of an expected shape of the hub in OSS data; searching measured OSS data to match the hub template to determine a hub position in the OSS data; and determining a registration between the two or more OSS enabled instruments by finding overlap in the OSS data relative to the hub position.
• OSS optical shape sensing
• FIG. 1 is a block/flow diagram showing a shape sensing system which employs a hub for registering two or more optical shape sensing (OSS) instruments in accordance with one embodiment
• FIG. 2A is a cross-sectional view of a hub design in accordance with one illustrative embodiment
• FIG. 2B is a cross-sectional view of a hub design showing a distinctive shape for identifying a position of the hub in shape data in accordance with one illustrative embodiment
• FIG. 3 is a cross-sectional view of a hub design where the hub is integrally formed in one of the OSS enabled instruments in accordance with one illustrative embodiment
• FIG. 4 is a flow diagram showing a method for shape-to-shape registration in accordance with an illustrative embodiment
• FIG. 5 shows a plot of a reciprocal of radius of curvature (1/ROC in mm) versus fiber node for three different hub positions on an optical fiber in accordance with an illustrative embodiment
• FIG. 6 is a plot of Kappa versus fiber node showing an example of a hub template employed to identify the hub in OSS data in accordance with an illustrative embodiment
• FIG. 7 A shows a plot of absolute value of a difference between outputs of two shape sensing devices (a guidewire and a catheter ) versus offset between the two shape sensing devices, a fluctuation in the plot indicates a position of the hub in accordance with an illustrative embodiment
• FIG. 7B is a plot of Kappa versus fiber node showing a region of constant Kappa distal to the hub where the two shape sensing devices are aligned in accordance with an illustrative embodiment
• FIG. 8 is a plot of Kappa versus fiber node showing a region distal to the hub where the two shape sensing devices are registered in accordance with an illustrative embodiment
• FIG. 9A is a diagram showing an OSS enabled guide wire and an OSS enabled catheter shown registered in a pre-operative image of a blood vessel in accordance with an illustrative embodiment
• FIG. 9B is a diagram showing an OSS enabled guide wire and an OSS enabled catheter shown offset from each other in a pre-operative image of a blood vessel;
• FIG. 10 is a split-half view of a hub design in accordance with another illustrative embodiment
• FIG. 1 1 is a split-half view of a hub design in accordance with yet another illustrative embodiment
• FIG. 12 shows three illustrative feature configurations for identifying a hub design is OSS data in accordance with illustrative embodiments; and FIG. 13 is a split-half view of a hub design showing tracks for three OSS enabled devices in accordance with yet another illustrative embodiment.
• a hub device includes a combination of straight and/or curved sections to create a pattern in a shape curvature that is unique and easily identifiable in an optical shape sensing (OSS) system.
• OSS optical shape sensing
• a position of the hub along a length of a first instrument e.g., a catheter
• a position of the hub along a length of a second instrument e.g., a guide wire
• the shape sensing fiber of the first instrument By detecting the unique curvature pattern (straight-curved-straight, curved-straight-curved, curved- straight, straight-curved, etc., for example) in the shape sensing fiber of the first instrument, it is possible to identify the portion of the second instrument that shares a geometric relationship with the first instrument (e.g., lies within it or next to it, etc.). Then, a registration between those two fibers can be performed using a curvature-based or shape-based implementation.
• the unique curvature pattern straight-curved-straight, curved-straight-curved, curved- straight, straight-curved, etc., for example
• the hub includes a carefully selected shape for the position where the second instrument, e.g., enters the first instrument.
• the hub makes it possible to perform real-time shape-to-shape registration between the two instruments.
• the hub can also be employed for torqueing the instruments.
• the present principles apply to any integration of optical shape sensing into medical devices where two devices are employed that have a known geometry with respect to each other. In particularly useful embodiments, this applies to guidewires and catheters (either manually and/or robotically controlled), but could be extended to endoscopes, bronchoscopes, etc. and other such applications.
• OSS employs light along a multicore optical fiber for device localization and navigation during surgical intervention.
• One principle involved makes use of distributed strain measurements in the optical fiber using characteristic Rayleigh backscatter or controlled grating patterns (Fiber Bragg Gratings (FBGs)).
• FBGs Fiber Bragg Gratings
• each of these instruments needs to be registered to an imaging frame of reference.
• subsequent devices can simply be registered to that first instrument. Registration between devices is known as 'shape-to-shape' registration.
• the present principles provide a hub design for the entry point of, e.g., a guidewire to a catheter, that provides for operator torqueing and handling and shape-to-shape registration between the two or more OSS enabled instruments.
• Torqueing is an element of navigation employed for manually steering instruments.
• Torqueing is an element of navigation employed for manually steering instruments.
• an easily graspable handle or feature along the instrument For example, instrument operators normally gravitate to the location at the guidewire entry point with the catheter as a feature for torqueing and manipulating the catheter.
• a hub design that provides adequate gripping and handling features.
• Another advantage to mechanically constraining this joint is to improve the optical shape sensing stability. Any joint or transition point along the instrument has the potential to introduce errors or instability in the shape reconstruction.
• the hub design buffers the fiber from pinching and excessive curvature or tension.
• Optical shape sensing can occasionally reconstruct an incorrect shape. This can be due to error in the reconstruction due to proximal shape changes, vibration during the
• OSS enabled instruments e.g., a guidewire and a catheter
• shapes may overlap from the point of entry of the catheter to the end of either the catheter or guidewire. By registering the two instruments together, incorrect shapes can be corrected or bad shapes can be removed from the data stream. If both devices have a known fixed launch point, the hub can be employed as an extra control point to filter outliers and compensate for error.
• the present invention will be described in terms of medical instruments; however, the teachings of the present invention are much broader and are applicable to any fiber optic shape sensing instruments.
• the present principles are employed in tracking or analyzing complex biological or mechanical systems.
• the present principles are applicable to internal tracking procedures of biological systems, procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc.
• the elements depicted in the FIGS may be implemented in various combinations of hardware and software and provide functions which may be combined in a single element or multiple elements.
• processors can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software.
• the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared.
• explicit use of the term "processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor ("DSP”) hardware, read-only memory (“ROM”) for storing software, random access memory
• DSP digital signal processor
• ROM read-only memory
• RAM random access memory
• non-volatile storage etc.
• embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system.
• a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.
• the medium can be an electronic, magnetic, optical,
• Examples of a computer-readable medium include a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk.
• Current examples of optical disks include compact disk - read only memory (CD-ROM), compact disk - read/write (CD-R/W), Blu-RayTM and DVD.
• System 100 may include a workstation or console 1 12 from which a procedure is supervised and/or managed.
• Workstation 1 12 preferably includes one or more processors 1 14 and memory 1 16 for storing programs and applications.
• Memory 1 16 may store an optical sensing module 1 15 configured to interpret optical feedback signals from a shape sensing device (optical fiber(s)) or system 104.
• Optical sensing module 1 15 is configured to use the optical signal feedback (and any other feedback, e.g., electromagnetic (EM) tracking) to reconstruct deformations, deflections and other changes associated with OSS enabled medical devices or instruments 102 and/or their surrounding regions.
• the medical instruments 102 may include a catheter, a guidewire, a probe, an endoscope, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.
• Optical sensing module 1 15 is configured to provide shape-to-shape registration between medical instruments 102.
• Optical sensing module 1 15 may include template search or other registration algorithms, filtering or data fitting algorithms, etc. as will be described herein.
• a plurality of OSS enabled medical instruments 102 are employed together.
• an instrument hub or hub 130 is employed.
• the hub 130 is depicted to show mechanical features 132 for aligning or registering the instruments 102.
• the hub 130 may include a polymeric, metal, ceramic or other material suitable for operating or clinical environments. Vibration due to handling of OSS enabled medical instruments 102 is a known limitation to the optical shape sensing performance. This can be mitigated at the hub 130 by employing a vibration- dampening material (e.g., foam or other materials) for manufacturing the hub 130.
• the hub 130 may include foam portions or may be formed completely from vibration dampening materials.
• the hub 130 receives a first shape sensing system 104a from a first optical
• the hub 130 diverts, within acceptable constraints, the two systems 104a and 104b to register the two systems 104a and 104b. The registration may be achieved by the hub 130 by holding/maintaining the two systems 104a and 104b next to each other, by making the two systems 104a and 104b coincident, by making the two systems 104a and 104b collinear, etc.
• the hub 130 is configured to physically maintain a geometrical relationship between the two (or more) systems 104a and 104b so that common
• reconstruction points are shared or can be identified to provide automatic registration between the two (or more) systems 104a and 104b.
• the hub 130 may include other features to permit ergonomic use or to permit improved navigation or manipulation of the two systems 104a and 104b.
• the features may include a hand grip 133 for ease of use by a clinician.
• the grip 133 may include a moment arm 134 to enable torqueing of the hub 130 with multiple shape sensing devices 104 therethrough.
• Other features may include mechanical clamps 136 or other clamping technology to restrict motion of the two systems 104a and 104b.
• the hub 130 includes tracks 138 for placement of the systems 104a and 104b therein. These tracks 138 are configured to provide a unique and identifiable shape within the shape sensed reconstruction. In addition, these tracks 138 ensure that the minimum bend radius and other physical constraints are maintained by the hub 130.
• the hub design may be modified to accommodate the structural constraints thereof.
• the hub 130 may include adjustment mechanisms or inserts 140 to accommodate different sized or shaped instruments 102 and/or provide accommodation for additional (e.g., more than two) systems 104.
• the instruments 102 include a catheter 102b and a guidewire 102a. Each of these two instruments 102a and 102b includes a shape sensing system 104a, and 104b coupled therein or thereto. OSS systems 104a, 104b may also be collectively referred to as system(s) 104. Each of the shape sensing systems 104a, 104b on instruments 102a, 102b, respectively, include one or more optical fibers (not shown), which are coupled to the instruments 102a, 102b in a set pattern or patterns. The optical fibers connect to the workstation 1 12 through interrogation modules 1 17a and 1 17b, which may be part of the console 1 12 or may be independent modules. Interrogation modules 1 17a and 1 17b send and receive light signals to and from their respective OSS system 104a and 104b. Other cabling may include fiber optics, electrical connections, other instrumentation, etc., as needed to power or operate instruments 102.
• Shape sensing systems 104 with fiber optics may be based on fiber optic Bragg grating sensors.
• a fiber optic Bragg grating (FBG) is a short segment of optical fiber that reflects particular wavelengths of light and transmits all others. This is achieved by adding a periodic variation of the refractive index in the fiber core, which generates a wavelength-specific dielectric mirror.
• a fiber Bragg grating can therefore be used as an inline optical filter to block certain wavelengths, or as a wavelength-specific reflector.
• a fundamental principle behind the operation of a fiber Bragg grating is Fresnel reflection at each of the interfaces where the refractive index is changing. For some wavelengths, the reflected light of the various periods is in phase so that constructive interference exists for reflection and, consequently, destructive interference for transmission.
• the Bragg wavelength is sensitive to strain as well as to temperature. This means that Bragg gratings can be used as sensing elements in fiber optical sensors. In an FBG sensor, the measurand (e.g., strain) causes a shift in the Bragg wavelength.
• One advantage of this technique is that various sensor elements can be distributed over the length of a fiber. Incorporating three or more cores with various sensors (gauges) along the length of a fiber that are embedded in a structure permits a three dimensional form of such a structure to be precisely determined, typically with better than 1 mm accuracy.
• a multitude of FBG sensors can be located (e.g., 3 or more fiber sensing cores). From the strain measurement of each FBG, the curvature of the structure can be inferred at that position. From the multitude of measured positions, the total three-dimensional form is determined.
• workstation 112 includes an image generation module 148 configured to receive feedback from the shape sensing system or device 104 and record accumulated position data as to where the sensing device 104 has been within a volume 131 (e.g., a living subject, a mechanical device, ductwork, etc.).
• An image or image data 135 of the shape sensing instrument s) 104 within the space or volume 131, generated by the module 148, can be displayed on a display device 118.
• Workstation 112 includes the display 118 for viewing internal images of a subject (patient) or volume 131 and may include the image 135 as an overlay (e.g., on operative images) or other rendering of visited positions of the sensing systems 104.
• Display 118 may also permit a user to interact with the workstation 112 and its components and functions, or any other element within the system 100. This is further facilitated by an interface 120 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 112.
• an interface 120 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 112.
• an illustrative hub design 200 is shown in accordance with the present principles. Shape-to-shape registration is provided automatically using the hub design 200.
• the hub design 200 includes a straight portion 202 that is preferably at least about 60 mm. This straight section 202 may be common to two or more shape sensing systems (104) and may be part of the physical constraints employed for identification and registration of the systems 104.
• the hub design 200 preferably includes an ergonomic design suitable for gripping and manipulating the hub system 200 with OSS systems 104 therein.
• the hub design 200 provides improved torqueing.
• the size and the shape of the hub design 200 include a natural feature size configured for a hand of a clinician to hold, while also transmitting, or providing a capability to apply, torque directly to a main shaft of a catheter or other instrument 102.
• the hub design 200 provides for handling a plurality of instruments 102 together. For example, both a catheter and a guidewire are held together and the geometry between these instruments is constrained, e.g., limits the angle of entry between the catheter and the guidewire.
• Each instrument 102 may by clamped or otherwise secured in the hub 200 by employing a clamp 208.
• Clamps 208 may include split half-chucks, include a compression fitting with a thumb screw to apply pressure to an outside diameter of the instrument 102, include a clip, or any other suitable clamping technology.
• the hub 200 is shown in cross- section and may be made split-half or may include a hollow cavity for inserting the instruments therein.
• the hub 200 may include a longitudinal body 210 forming a cavity or track 212 configured to receive at least one OSS enabled instrument 102b.
• the body 210 includes one or more mechanical features disposed within the cavity or on the longitudinal body 210 to maintain two or more OSS enabled instruments in a fixed geometrical configuration relative to one another such that distally to the longitudinal body 210, the two or more OSS enabled instruments have shape sensed reconstruction data registered therebetween.
• the mechanical features may include the clamps 208, additional bodies or structures, e.g., an angled channel 220, for guiding at least one OSS enabled instrument (102a), tracks/cavities 212 and/or 214 for maintaining positions of the OSS enabled devices 102, etc.
• Other mechanical features include radiused tracks (e.g., having a bend radius that exceeds a minimum bend radius of an optical fiber employed for at least one of the two or more OSS enabled instruments), spacers, guides curved surfaces, etc.
• the longitudinal body 210 is configured to receive the OSS enabled device 102b longitudinally therein, and the longitudinal body 210 is also configured with an angled channel 220 to receive the OSS enabled device 102a into the longitudinal body 210 such that when the OSS enabled devices are mounted in the
• the first and second OSS enabled devices 102a, 102b are positioned coaxially at a distal end portion of the longitudinal body 210.
• a radially extending portion 216 extends from the longitudinal body 210 and is configured to provide a torque arm for rotating the hub 200.
• the radially extending portion 216 may be provided at any convenient or advantageous position along the hub 200 including being combined with other features (e.g., the angled channel 220, etc.).
• a hub design 201 preferably includes a detectable registration feature 230.
• This may include a straight-curved-straight shape (shown ion FIG. 2B) or a curved-straight-curved, curved- straight, etc.
• the detectable registration feature 230 is configured to provide a shape to the two or more OSS enabled instruments to provide a distinct feature for locating the hub 201 in OSS data.
• the detectable registration feature 230 includes at least one curved portion 232.
• ROC radius of curvature
• the material for the hub design(s) 200, 201 should include low friction materials, such as, polymeric materials (e.g., polyethylene) or metals (aluminum, stainless, steel), etc.
• the hub design 200, 201 should not include small radii of curvature bends as they reduce the shape accuracy.
• a gentle radius of curvature should be employed (e.g., >30 mm ROC).
• a hub 302 is shown integrated into a catheter 300.
• longitudinal body 210 is integrally formed as one of the two or more OSS enabled instruments and includes a receiving feature 308 configured to receive at least one other OSS enabled instrument.
• the hub 302 may be manufactured to be integrally formed with the catheter 300 (or any other device). In one example, the catheter 300 is molded on or with the hub 302, which reduces its form factor and improves its ergonomics.
• the hub 302 may include insertion points 304 and clamps 306 to mount one or more other OSS enabled devices.
• a method for shape-to-shape registration is described for registering two or more an optical shape sensing (OSS) enabled instruments using a hub design in accordance with the present principles.
• OSS optical shape sensing
• an optical shape sensing hub comprising a longitudinal body forming a cavity configured to receive two or more optical shape sensing (OSS) enabled instruments, and one or more mechanical features disposed within the cavity or on the longitudinal body to maintain the two or more OSS enabled instruments in a fixed geometrical configuration relative to one another such that distally to the longitudinal body the two or more OSS enabled instruments have shape sensed reconstruction data registered therebetween.
• OSS optical shape sensing
• the hub By employing a unique shape (e.g., a straight-curved-straight shape), the hub provides a curvature/shape for facilitating registration.
• a template of an expected curvature for the hub is generated.
• the hub template of expected shape is generated in OSS data.
• the expected shape is preferably an identifiable shape(s) (e.g., straight-curved-straight, etc.). This can be performed in a plurality of ways.
• a known curvature of the hub is employed (e.g., the straight-curved-straight shape).
• the shape of the hub geometry can be vectorized and assuming the optical fiber takes the shortest available path, the curvatures in the shape are filtered to uniquely identify the hub position.
• the fiber and device will take the shortest path, which can be approximated by filtering discrete jumps in expected curvature.
• the hub template is generated using a curvature of a test device.
• a device that generates the template shape as an OSS output may be defined by the test device or devices positioned inside the hub or a specific external test device.
• the hub template may be generated using a computed average from different measurements or other computed shape. The average or other combinations of different measurements or computations from one or several OSS enabled devices may be employed to locate the hub in the data.
• a reciprocal of radius of curvature (1/ROC in mm) is plotted versus fiber node for three different hub positions with respect to the fiber indicated by 502, 504 and 506.
• a known curved shape is indicated by 502, 504 and 506, which is highly unlikely to exist somewhere else along the fiber with the exact same curvature pattern.
• Completely straight segments are not necessarily unique; however, combined with a curved part, the pattern is longer and therefore more unique. Also, using a straight section improves the need for low friction.
• the curvature may be made smaller than a possible bend radius of the instrument. This may be employed for the fiber with the catheter for example. This bend will only occur inside the hub and is therefore uniquely detectable.
• the graph of FIG. 5 shows a unique and identifiable pattern for locating the hub in the data using the curved-straight-curved shape. As the hub is translated along the fiber, the position of the hub indicated by 502, 504 and 506 is easily identified by the pattern in the curvature. The identifiable pattern is then employed to match the hub in the data.
• FIG. 6 shows an example of a template 508 employed to identify the hub in OSS data.
• a template- matching algorithm may be run along the length of the fiber. This can be simply a difference between the template and a selected section of fiber.
• a minimum value of this matching algorithm will indicate the location of the hub and therefore the relationship between first and second OSS enabled devices.
• the fiber node at which the first OSS enabled device (a guidewire) enters a center lumen of the second OSS enabled device (a catheter) is known. From that point onwards, the two devices will have the same shape until either the guide wire or catheter ends. The algorithm continues:
• Kappa is a parameter indicating the curvature of the fiber
• the location of the minimum coefficient is the location of the hub along the device (i.e., the point of the guidewire that has been inserted into the hub - this determines the offset between the guidewire and the catheter) (see FIG. 7B).
• an absolute value of the difference in curvature between outputs of two shape sensing devices is plotted for different offset values between the guidewire and catheter.
• a local minimum 512 in the graph indicates the position of the hub.
• Kappa is plotted against fiber node or index (idx).
• a region 516 to the right of a fluctuation region 514 (hub position) indicates constant Kappa for the guidewire and catheter distal to the hub.
• a validation check may be run by checking a correlation between segments of the first and second OSS enabled instruments that are distal to the hub.
• the validation check or correlation may be provided as an alignment check between OSS data of the two or more OSS enabled instruments.
• the correlation may be for one or more of curvature, shape or strain.
• Kappa is plotted against fiber node or index (idx).
• traces of the OSS enabled catheter and guidewire are not the same, as expected as they are not mechanically coupled in that region.
• traces of the OSS enabled catheter and guidewire are registered and the traces are in alignment, reflecting that the guidewire is located within the catheter from the hub location onwards, thereby assuming identical curvature.
• a registration is determined between the two or more OSS enabled instruments by finding overlap in the OSS data relative to the hub position.
• a registration between overlapping portions of the first and second OSS enabled instruments may be computed using a rigid transformation.
• the rigid transformation may be computed between OSS data of the two or more OSS enabled instruments, and the computation between the two shapes may employ known transformation tools (e.g., ProcrustesTM or similar programs).
• known transformation tools e.g., ProcrustesTM or similar programs.
• incorrect shapes of the instruments can be determined based upon the registration. These incorrect shapes may be considered outliers and removed from the data set.
• the unique shape of the hub design may be employed with one OSS enabled device, with two or more OSS enabled devices using a same unique shape of the hub design or with each OSS enabled device having its own unique shape of the hub design.
• the location of the hub along a catheter is also known (e.g., mechanically defined).
• the location of the hub along the catheter could also be extracted using the same technique as is used for the guidewire (e.g., the curvature template matching described above).
• An additional advantage is that the rotation in relation to the hub would also be known, which cannot be easily derived from a straight path in which the fiber can twist freely.
• a hub with a straight-curved-straight (or other combinations thereof) path where one device enters another can be easily detectable; however, other geometric relationships may be provided that begin at the hub.
• the two devices may be held side-by-side, or be included in different portions of a same instruments or structure, etc.
• the shape-sensed devices need to be registered to an imaging frame of reference (such as, e.g., a pre-operative computed topography (CT) image, a live fluoroscopy image, etc.).
• An OSS enabled guidewire 602 and an OSS enabled catheter 604 are shown registered to a pre-operative image 606 of a blood vessel 610 in FIG. 9A.
• the OSS enabled guidewire 602 and an OSS enabled catheter 604 are shown poorly registered (offset) in a pre-operative image 608 of the blood vessel 610 in FIG. 9B.
• a hub 700 includes a longitudinal body 710 having Y-shape and shown split-half.
• a web portion 722 may be employed to provide support or strength to the design of the hub 700 or to provide useful features (a grip, holes for hanging the device, etc.).
• the longitudinal body 710 includes a straight portion 724 that diverges into a curved portion 718 and an extended portion 720.
• the curved portion 718, the extended portion 720 or both can contribute to a unique hub shape for locating the hub 700 in OSS data.
• a first OSS enabled device 702a enters the curved portion 718 through a cavity 708 formed in an end portion 716.
• the cavity 708 may include a tapered or funnel-like shape 714 to aid in the insertion of the OSS enabled device 702a.
• a second OSS enabled device 702b enters the extended portion 720 and the OSS enabled devices 702a and 702b are joined in a chamber 712 and exit a distal end portion 726.
• the configuration of the OSS enabled devices 702a and 702b can be employed to identify the hub 700 in OSS data.
• a hub 800 includes a longitudinal body 810 having a unitary configuration and split-half.
• a connection portion 822 may include a solid material employed to provide support or strength to the design of the hub 800 or to provide useful features (holes or pins for connecting its mating half, etc.).
• the longitudinal body 810 includes a straight portion or track 824 that diverges into a curved portion or track 818 and an extended portion 820.
• the curved portion 818, the extended portion 820 or both can contribute to a unique hub shape for locating the hub 800 in OSS data.
• the curved portion includes multiple bends to contribute to the uniqueness of the shapes.
• a first OSS enabled device (not shown) can enter the curved portion 818 through a cavity 808 formed in an end portion 816.
• the cavity 808 may include a tapered or funnel-like shape 814 to aid in the insertion of the OSS enabled device.
• a second OSS enabled device (not shown) enters the extended portion 820 and the OSS enabled devices are joined in a chamber 812 and exit a distal end portion 826.
• the configuration of the OSS enabled devices can be employed to identify the hub 800 in OSS data.
• Configuration 902 includes a straight portion and a curved portion.
• Configuration 904 includes a straight portion and two curved portions.
• Configuration 906 includes a Y-shaped portion (a curve on each OSS device track) and a common straight portion. It should be understood that other configurations are contemplated and that the configurations depicted in FIG. 12 are for illustrative purposes only.
• a hub 1000 includes features, as described with respect to FIG. 1 1 , but includes an additional curved track 818, end portion 816 and entry 814 for receiving an additional OSS enabled device.
• the hub 1000 may receive an OSS enabled endoscope (not shown) in track 820.
• the endoscope may include a working channel.
• the hub 1000 may also include tracks 818 for one or more OSS enabled catheters, guidewires, etc.
• the OSS enabled devices in tracks 818 may be passed through the hub 1000 and into the working channel of the endoscope and registered as described above. Other instruments and combinations are also contemplated.

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• 2014
  • 2014-09-19 EP EP14786542.2A patent/EP3052021A2/de not_active Withdrawn
  • 2014-09-19 US US15/025,900 patent/US20160213432A1/en not_active Abandoned
  • 2014-09-19 WO PCT/IB2014/064647 patent/WO2015049612A2/en not_active Ceased
  • 2014-09-19 CN CN201480054520.9A patent/CN105592790A/zh active Pending

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